FDA Adverse Event
Summary report: N
INSYNC MAXIMO
MDR report key: 1182307
·
Received September 17, 2008
Report
- Report Number
- 1182307
- Date Received
- September 17, 2008
- Date of Event
- July 17, 2008
- Report Date
- September 15, 2008
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LWS
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
HIGH CAPTURE THRESHOLDS. LENGTH NOT LONG ENOUGH FOR OPTIMAL CORONARY SINUS POSITIONING. OUTER DIAMETER TOO LARGE FOR OPTIMAL CORONARY SINUS POSITIONING. PATIENT IS A 67 YEAR OLD MALE WITH MULTIPLE COMORBIDITIES AND UNDERWENT BIVENTRICULAR AUTOMATIC IMPLANTABLE CARDIOVERTER DEFBRILLATOR IMPLANT IN 2005. HE STATES THAT HE HAS BEEN FEELING MORE FATIGUED AND SHORT OF BREATH LATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC MAXIMO | ICD | LWS | MEDTRONIC INC. | 7303 | NA | |
| 2 | SPRINT FIDELIS | LEAD WIRE, ICD | LWS | MEDTRONIC INC. | 6949-65 | NA | |
| 3 | ATTAIN | LEAD WIRE, CRT | LWS | MEDTRONIC INC. | 4193-88 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |